GUEST COLUMNISTS

• Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation

  Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

• A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis

  This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

• Managing Organic Impurities And Nitrosamines In APIs

  How API manufacturers can assess and mitigate organic impurities and nitrosamines using risk-based strategies aligned with global regulatory expectations.

• AI Has Arrived In Biotech CMC Amid Patchwork Governance

  AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.

• Avoiding Common Pitfalls In CDMO–Sponsor Relationships Through Integrated Execution Models

  Let's delve into the key pitfalls to avoid when working with a CDMO and the integrated execution model that solves or mitigates these pitfalls before they occur.

• The Future Of Continuous Is Integrated Manufacturing: The 4 Misconceptions About A Lean Process

  Pharmaceutical continuous manufacturing is an enabler of better manufacturing, but only when implemented with intention.

• CDMO Selection: Start With The Relationship, Not The RFP

  Friction often comes from unspoken expectations. Before production begins, treat the combined sponsor-CDMO group as one extended team and intentionally make “how we work together” visible.

• Why FAT Should Confirm Alignment, Not Reveal Its Absence

  In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.